Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID aaccfd13-6559-4976-90d1-aa3b4a4a79db
Route
ORAL
Published
Effective Date 2023-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_X]) Centella Asiatica Flowering Top (12 [hp_X]) Ambergris (18 [hp_X]) Silver Cation Anamirta Cocculus Seed Conium Maculatum Flowering Top Canis Lupus Familiaris Milk Theridion Curassavicum
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-02-20

Description

Arnica Montana 3X, Hydrocotyle Asiatica 3X, Ambra Grisea 12X, Argentum Nitricum 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Lac Caninum 12X, Theridion 18X.

Purpose

For temporary relief of dizziness, light headedness, and sensations of motion or spinning.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

For temporary relief of dizziness, light headedness, and sensations of motion or spinning.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Arnica Montana 3X, Hydrocotyle Asiatica 3X, Ambra Grisea 12X, Argentum Nitricum 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Lac Caninum 12X, Theridion 18X.

Purpose:

For temporary relief of dizziness, light headedness, and sensations of motion or spinning.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of dizziness, light headedness, and sensations of motion or spinning.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

Arnica Montana 3X, Hydrocotyle Asiatica 3X, Ambra Grisea 12X, Argentum Nitricum 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Lac Caninum 12X, Theridion 18X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0001-1

DIZZY

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

For temporary relief of dizziness, light headedness, and sensations of motion or spinning.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of dizziness, light headedness, and sensations of motion or spinning.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

Arnica Montana 3X, Hydrocotyle Asiatica 3X, Ambra Grisea 12X, Argentum Nitricum 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Lac Caninum 12X, Theridion 18X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0001-1

DIZZY

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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